Phase 2 Dose-Response Study Evaluating the Safety and Efficacy of NCX 470 vs Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension

NicOx

Status and phase: Completed; Phase 2

Conditions: Hypertension, Ocular; Glaucoma, Open-Angle

Treatments: Drug: NCX 470; Drug: Latanoprost 0.005%

Study type: Interventional

Funder types: Industry

Identifiers

NCT03657797

NCX-470-17001

Details and patient eligibility

About

The objective of this clinical study is to evaluate the safety and efficacy of NCX 470 ophthalmic solution in lowering intraocular pressure (IOP) in patients with ocular hypertension or open-angle glaucoma. Three different concentrations of NCX 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.

Enrollment: 656 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of open-angle glaucoma or ocular hypertension in both eyes
• Qualifying IOP at 3 time points throughout the day at 2 visits following washout of IOP-lowering medication, if applicable
• Qualifying best-corrected visual acuity (BCVA) using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol in each eye
• Ability to provide informed consent and follow study instructions

Exclusion criteria

• Pigmentary or pseudoexfoliative glaucoma
• Narrow anterior chamber angles or disqualifying corneal thickness in either eye
• Clinically significant ocular disease in either eye
• Previous complicated surgery or certain types of glaucoma surgery in either eye
• Incisional ocular surgery or severe trauma in either eye within the past 6 months
• Uncontrolled systemic disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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656 participants in 4 patient groups

NCX 470 0.021%

Experimental group

Description:

NCX 470 Ophthalmic Solution, 0.021% dosed once daily for 4 weeks

Treatment:

Drug: NCX 470

NCX 470 0.042%

Experimental group

Description:

NCX 470 Ophthalmic Solution, 0.042% dosed once daily for 4 weeks

Treatment:

Drug: NCX 470

NCX 470 0.065%

Experimental group

Description:

NCX 470 Ophthalmic Solution, 0.065% dosed once daily for 4 weeks

Treatment:

Drug: NCX 470

Latanoprost 0.005%

Active Comparator group

Description:

Latanoprost Ophthalmic Solution, 0.005% dosed once daily for 4 weeks

Treatment:

Drug: Latanoprost 0.005%